FDA Proposes Daily Value for Added Sugars

Last week, FDA announced a supplemental proposal to amend the nutrition labeling regulation for food and dietary supplements, and the availability of consumer studies related to FDA’s proposed changes to the format of the Nutrition Facts box.

Undoubtedly, the proprosal to establish a Daily Reference Value (DRV) for added sugars will receive the most attention. FDA proposes a DRV of 10% of the total energy intake from added sugars, i.e., a DRV of 50 grams for adults and children above 4 years and a DRV of 25 g for children aged one to three. This DRV would be used in calculating the percent Daily Value (%DV) that FDA proposes to require when the quantitative amount of “Added Sugars” must be declared.

In the 2014 proposed rule, FDA included a requirement for the amount of added sugars (see our previous post here). FDA proposed to require an added sugar declaration even though, at that time, the “U.S. consensus reports [had] determined that inadequate evidence exist[ed] to support the direct contribution of added sugars to obesity or heart disease.” The Agency proposed a mandatory declaration of added sugars to provide “consumers with the information necessary to follow the 2010 [Dietary Guidelines] to reduce the intake of calories from added sugars.” However, FDA drew the line at setting a DRV, because, at that time, there was no “sound scientific basis for the establishment of a quantitative intake recommendation [from] which a DRV could be derived.” Perhaps somewhat surprisingly, a little over a year later, the Agency is finding a sound scientific basis. FDA’s change of heart is based, at least in part, on evidence in the 2015 Dietary Guidelines Advisory Committee (DGAC) report, which is still in draft and has not yet been adopted by HHS and USDA.

The proposal to require a declaration of “added sugars” probably has been the most contested aspect of the proposed amendment of the nutrition labeling regulations. The supplemental proposal undoubtedly will relight that fire.

In a related development, FDA proposes to replace the term “Sugars” with “Total Sugars,” based on comments to the proposed rule and the results of two consumer studies that have become available. However, according to FDA, there is still no scientific basis to set a DRV for total sugars.

FDA’s supplemental proposal also addresses the footnote in the Nutrition Facts box. In the original proposal, FDA proposed to maintain the footnote for the Supplement Facts box but requested feedback regarding a revised footnote for the Nutrition Facts box. FDA now proposes to simplify the footnote in the Nutrition Facts box to state “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice,” and queries whether the footnote in the Supplements Facts box should be revised in a similar manner.

Comments on the supplemental proposal are due October 12, 2015. Comments must be limited to the footnote, the DRV for added sugars, the percent DV declaration for added sugars, and the new information from the DGAC report for the added sugars declaration.

In addition to issuing the supplemental proposal, FDA announced a reopening of the comment period for the proposed rule. FDA performed two consumer studies –a study regarding the potential effects of several possible changes to the label on consumer viewing and use of the label, and a study to explore whether modifications to the format of the Nutrition Facts box would affect consumers’ interpretation of information in the Nutrition Facts box. The results of these studies are being made available and the comment period has been reopened to allow for public comments on these studies. Comments related to the two consumer studies are due September 25, 2015.